Regulatory Writing

Provided with courtesy of Dr. Lukasz Preibisz

Dealing with clinical documents required by ethics committees, health authorities or market access agencies

  • Study synopsis, protocols/CIP and amendments
  • Clinical investigation/study reports (CIR/CSR)
  • Case report forms (CRF)
  • Ethics committees- and health authorities application forms
  • Investigator’s brochures (IB)
  • Patient brochures
  • Patient information sheets
  • Patient informed consent forms (ICF)
  • Manuals of operations
  • Clinical evaluation reports (CER) for medical devices
  • Answering to deficiency letters
  • Product labelling: summary of product characteristics (SmPC) and instructions for use (IFU)
  • Clinical modules of marketing authorisation applications (clinical summary and overview, like summary of safety and efficacy) for European notify bodies and FDA

Scope of clinical studies:

  • Phases I-IV studies (pharmaceuticals drugs)
  • Pilot/pivotal/PMCF studies (medical devices)
  • Non-interventional studies/programs (NIS/NIP)
  • Registries
  • Investigator-initiated trial (IIT)